Healwell Homeo Private Limited
FDA issued a warning letter to Healwell Homeo Private Limited, an Indian manufacturer of homeopathic and OTC drug products, following a December 2024 inspection that found pervasive insanitary conditions including live rodents, birds, rodent and avian excreta, mold, insects, and stray dogs in manufacturing and storage areas. The firm also failed to conduct identity testing on incoming components and lacked adequate quality unit oversight, written procedures, and process validation. FDA placed the firm on Import Alert 66-40, a distributor-initiated recall of U.S.-distributed products was executed in April 2025, and the firm is required to respond with corrective actions within 15 working days.
Required actions (5)
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 31, 2025.
On April 8, 2025, (b)(4), initiated a recall of products manufactured at your facility, currently in U.S. distribution.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Healwell Homeo Private Limited, FEI 3028192440, Plot No. 215/1 220/1 & 221/1, Village Indrad, Tal Kadi, District Mehsana, Ahmedabad, Gujarat, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker